Other safety alerts
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| Canada: Important Safety Information: NUVARING (etonogestrel / ethinyl estradiol slow release vaginal ring) - New Contraindications |
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Merck Canada Inc., in consultation with Health Canada, would like to inform you of new contraindications that have been added to the NUVARING Product Monograph (PM).
NUVARING is a combined hormonal contraceptive (CHC) indicated for conception control. The following points summarize the important changes that have been made to the PM:
- NUVARING should NOT be used by women who smoke (if over age 35), or who have severe or multiple risk factors for thrombosis, including: valvular heart disease with complications, hypertension, severe dyslipoproteinemia, abnormality in proteins that regulate coagulation, diabetes mellitus with vascular involvement, or major surgery with prolonged immobilization.
- NUVARING should NOT be used by women who have experienced migraines with focal neurological symptoms, or pancreatitis associated with severe hypertriglyceridemia.
- Prescribers should consider the above new contraindications and review the updated PM when discussing treatment options with their patients.
In addition to the above contraindications, changes have also been made under WARNINGS AND PRECAUTIONS section of the PM regarding the following possible adverse events: systemic lupus erythematosus, sydenham's chorea, herpes gestationis, otosclerosis-related hearing loss, hepatocellular carcinoma, Crohn's disease, colitis ulcerosa and angioedema. Merck Canada Inc., in working with Health Canada, has updated the NUVARING PM regarding the above new contraindications and warnings which are also associated with other CHC products.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../40839a-eng.php
In Hong Kong, Nuvaring Vaginal Rings (HK-55149) is a registered pharmaceutical product. It is registered by Merck Sharp & Dohme (Asia) Ltd. (MSD) and is a prescription-only medicine. MSD has submitted application to update the package insert of its product with new safety information similar to the Health Canada's announcement. So far, the Department of Health (DH) has not received any local adverse drug reaction report related to the product. In view of the Health Canada's announcement, a letter to local healthcare professionals will be issued and the above new safety information will be reported to the Registration Committee of the Pharmacy and Poisons Board for consideration. The DH will remain vigilant on safety updates and regulatory actions related to the drug decided by other overseas health authorities.
Ends/ Friday, August 01, 2014
Issued at HKT 13:00
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